Florida Senate - 2019                          SENATOR AMENDMENT
       Bill No. CS for HB 21
       
       
       
       
       
       
                                Ì485034ÊÎ485034                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/AD/2R         .            Floor: C            
             04/26/2019 12:46 PM       .      04/29/2019 05:27 PM       
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       Senator Harrell moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Subsection (10) of section 395.0191, Florida
    6  Statutes, is amended to read:
    7         395.0191 Staff membership and clinical privileges.—
    8         (10) Nothing herein shall be construed by the agency as
    9  requiring an applicant for a certificate of need to establish
   10  proof of discrimination in the granting of or denial of hospital
   11  staff membership or clinical privileges as a precondition to
   12  obtaining such certificate of need under the provisions of s.
   13  408.043.
   14         Section 2. Present subsection (12) of section 395.1055,
   15  Florida Statutes, is redesignated as subsection (15), a new
   16  subsection (12) and subsections (13) and (14) are added to that
   17  section, and paragraph (b) of subsection (9) of that section is
   18  amended, to read:
   19         395.1055 Rules and enforcement.—
   20         (9) The agency shall establish a technical advisory panel,
   21  pursuant to s. 20.052, to develop procedures and standards for
   22  measuring outcomes of pediatric cardiac catheterization programs
   23  and pediatric cardiovascular surgery programs.
   24         (b) Voting members of the panel shall include: 3 at-large
   25  members, including 1 cardiologist who is board certified in
   26  caring for adults with congenital heart disease and 2 board
   27  certified pediatric cardiologists, neither of whom may be
   28  employed by any of the hospitals specified in subparagraphs 1.
   29  10. or their affiliates, each of whom is appointed by the
   30  Secretary of Health Care Administration, and 10 members, and an
   31  alternate for each member, each of whom is a pediatric
   32  cardiologist or a pediatric cardiovascular surgeon, each
   33  appointed by the chief executive officer of the following
   34  hospitals:
   35         1. Johns Hopkins All Children’s Hospital in St. Petersburg.
   36         2. Arnold Palmer Hospital for Children in Orlando.
   37         3. Joe DiMaggio Children’s Hospital in Hollywood.
   38         4. Nicklaus Children’s Hospital in Miami.
   39         5. St. Joseph’s Children’s Hospital in Tampa.
   40         6. University of Florida Health Shands Hospital in
   41  Gainesville.
   42         7. University of Miami Holtz Children’s Hospital in Miami.
   43         8. Wolfson Children’s Hospital in Jacksonville.
   44         9. Florida Hospital for Children in Orlando.
   45         10. Nemours Children’s Hospital in Orlando.
   46  
   47  Appointments made under subparagraphs 1.-10. are contingent upon
   48  the hospital’s maintenance of pediatric certificates of need and
   49  the hospital’s compliance with this section and rules adopted
   50  thereunder, as determined by the Secretary of Health Care
   51  Administration. A member appointed under subparagraphs 1.-10.
   52  whose hospital fails to maintain such certificates or comply
   53  with such standards may serve only as a nonvoting member until
   54  the hospital restores such certificates or complies with such
   55  standards.
   56         (12)Each provider of diagnostic cardiac catheterization
   57  services shall comply with rules adopted by the agency which
   58  establish licensure standards governing the operation of adult
   59  inpatient diagnostic cardiac catheterization programs. The rules
   60  must ensure that such programs:
   61         (a)Comply with the most recent guidelines of the American
   62  College of Cardiology and American Heart Association Guidelines
   63  for Cardiac Catheterization and Cardiac Catheterization
   64  Laboratories.
   65         (b)Perform only adult inpatient diagnostic cardiac
   66  catheterization services and will not provide therapeutic
   67  cardiac catheterization or any other cardiology services.
   68         (c)Maintain sufficient appropriate equipment and health
   69  care personnel to ensure quality and safety.
   70         (d)Maintain appropriate times of operation and protocols
   71  to ensure availability and appropriate referrals in the event of
   72  emergencies.
   73         (e)Demonstrate a plan to provide services to Medicaid and
   74  charity care patients.
   75         (13)Each provider of adult cardiovascular services or
   76  operator of a burn unit shall comply with rules adopted by the
   77  agency which establish licensure standards that govern the
   78  provision of adult cardiovascular services or the operation of a
   79  burn unit, as applicable. At a minimum, such rules must address
   80  staffing, equipment, physical plant, operating protocols, the
   81  provision of services to Medicaid and charity care patients,
   82  accreditation, licensure periods and fees, and enforcement of
   83  minimum standards.
   84         (14)In establishing rules for adult cardiovascular
   85  services, the agency shall include provisions that allow for:
   86         (a)The establishment of two hospital program licensure
   87  levels, a Level I program that authorizes the performance of
   88  adult percutaneous cardiac intervention without onsite cardiac
   89  surgery and a Level II program that authorizes the performance
   90  of percutaneous cardiac intervention with onsite cardiac
   91  surgery.
   92         (b)1.For a hospital seeking a Level I program,
   93  demonstration that, for the most recent 12-month period as
   94  reported to the agency, the hospital has provided a minimum of
   95  300 adult inpatient and outpatient diagnostic cardiac
   96  catheterizations or, for the most recent 12-month period, has
   97  discharged or transferred at least 300 patients with the
   98  principal diagnosis of ischemic heart disease and that it has a
   99  formalized, written transfer agreement with a hospital that has
  100  a Level II program, including written transport protocols to
  101  ensure safe and efficient transfer of a patient within 60
  102  minutes.
  103         2.a.A hospital located more than 100 road miles from the
  104  closest Level II adult cardiovascular services program is not
  105  required to meet the diagnostic cardiac catheterization volume
  106  and ischemic heart disease diagnosis volume requirements in
  107  subparagraph 1. if the hospital demonstrates that it has, for
  108  the most recent 12-month period as reported to the agency,
  109  provided a minimum of 100 adult inpatient and outpatient
  110  diagnostic cardiac catheterizations or that, for the most recent
  111  12-month period, it has discharged or transferred at least 300
  112  patients with the principal diagnosis of ischemic heart disease.
  113         b.A hospital located more than 100 road miles from the
  114  closest Level II adult cardiovascular services program does not
  115  need to meet the 60-minute transfer time protocol requirement in
  116  subparagraph 1. if the hospital demonstrates that it has a
  117  formalized, written transfer agreement with a hospital that has
  118  a Level II program. The agreement must include written transport
  119  protocols to ensure the safe and efficient transfer of a
  120  patient, taking into consideration the patient’s clinical and
  121  physical characteristics, road and weather conditions, and
  122  viability of ground and air ambulance service to transfer the
  123  patient.
  124         3.At a minimum, the rules for adult cardiovascular
  125  services must require nursing and technical staff to have
  126  demonstrated experience in handling acutely ill patients
  127  requiring intervention, based on the staff member’s previous
  128  experience in dedicated cardiac interventional laboratories or
  129  surgical centers. If a staff member’s previous experience is in
  130  a dedicated cardiac interventional laboratory at a hospital that
  131  does not have an approved adult open heart surgery program, the
  132  staff member’s previous experience qualifies only if, at the
  133  time the staff member acquired his or her experience, the
  134  dedicated cardiac interventional laboratory:
  135         a.Had an annual volume of 500 or more percutaneous cardiac
  136  intervention procedures.
  137         b.Achieved a demonstrated success rate of 95 percent or
  138  greater for percutaneous cardiac intervention procedures.
  139         c.Experienced a complication rate of less than 5 percent
  140  for percutaneous cardiac intervention procedures.
  141         d.Performed diverse cardiac procedures, including, but not
  142  limited to, balloon angioplasty and stenting, rotational
  143  atherectomy, cutting balloon atheroma remodeling, and procedures
  144  relating to left ventricular support capability.
  145         (c)For a hospital seeking a Level II program,
  146  demonstration that, for the most recent 12-month period as
  147  reported to the agency, the hospital has performed a minimum of
  148  1,100 adult inpatient and outpatient cardiac catheterizations,
  149  of which at least 400 must be therapeutic catheterizations, or,
  150  for the most recent 12-month period, has discharged at least 800
  151  patients with the principal diagnosis of ischemic heart disease.
  152         (d)Compliance with the most recent guidelines of the
  153  American College of Cardiology and the American Heart
  154  Association guidelines for staffing, physician training and
  155  experience, operating procedures, equipment, physical plant, and
  156  patient selection criteria, to ensure patient quality and
  157  safety.
  158         (e)The establishment of appropriate hours of operation and
  159  protocols to ensure availability and timely referral in the
  160  event of emergencies.
  161         (f)The demonstration of a plan to provide services to
  162  Medicaid and charity care patients.
  163         Section 3. Effective July 1, 2021, paragraph (f) of
  164  subsection (1) of section 395.1055, Florida Statutes, is amended
  165  to read:
  166         395.1055 Rules and enforcement.—
  167         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
  168  and 120.54 to implement the provisions of this part, which shall
  169  include reasonable and fair minimum standards for ensuring that:
  170         (f) All hospitals submit such data as necessary to conduct
  171  certificate-of-need reviews required under part I of chapter
  172  408. Such data shall include, but shall not be limited to,
  173  patient origin data, hospital utilization data, type of service
  174  reporting, and facility staffing data. The agency may not
  175  collect data that identifies or could disclose the identity of
  176  individual patients. The agency shall utilize existing uniform
  177  statewide data sources when available and shall minimize
  178  reporting costs to hospitals.
  179         Section 4. Effective July 1, 2021, subsection (5) of
  180  section 395.1065, Florida Statutes, is amended to read:
  181         395.1065 Criminal and administrative penalties;
  182  moratorium.—
  183         (5) The agency shall impose a fine of $500 for each
  184  instance of the facility’s failure to provide the information
  185  required by rules adopted pursuant to s. 395.1055(1)(g) s.
  186  395.1055(1)(h).
  187         Section 5. Section 395.6025, Florida Statutes, is repealed.
  188         Section 6. Subsections (3), (8), and (13) through (17) of
  189  section 408.032, Florida Statutes, are amended to read:
  190         408.032 Definitions relating to Health Facility and
  191  Services Development Act.—As used in ss. 408.031-408.045, the
  192  term:
  193         (3) “Certificate of need” means a written statement issued
  194  by the agency evidencing community need for a new, converted,
  195  expanded, or otherwise significantly modified health care
  196  facility, health service, or hospice.
  197         (8) “Health care facility” means a hospital, long-term care
  198  hospital, skilled nursing facility, hospice, or intermediate
  199  care facility for the developmentally disabled. A facility
  200  relying solely on spiritual means through prayer for healing is
  201  not included as a health care facility.
  202         (13) “Long-term care hospital” means a hospital licensed
  203  under chapter 395 which meets the requirements of 42 C.F.R. s.
  204  412.23(e) and seeks exclusion from the acute care Medicare
  205  prospective payment system for inpatient hospital services.
  206         (14) “Mental health services” means inpatient services
  207  provided in a hospital licensed under chapter 395 and listed on
  208  the hospital license as psychiatric beds for adults; psychiatric
  209  beds for children and adolescents; intensive residential
  210  treatment beds for children and adolescents; substance abuse
  211  beds for adults; or substance abuse beds for children and
  212  adolescents.
  213         (13)(15) “Nursing home geographically underserved area”
  214  means:
  215         (a) A county in which there is no existing or approved
  216  nursing home;
  217         (b) An area with a radius of at least 20 miles in which
  218  there is no existing or approved nursing home; or
  219         (c) An area with a radius of at least 20 miles in which all
  220  existing nursing homes have maintained at least a 95 percent
  221  occupancy rate for the most recent 6 months or a 90 percent
  222  occupancy rate for the most recent 12 months.
  223         (14)(16) “Skilled nursing facility” means an institution,
  224  or a distinct part of an institution, which is primarily engaged
  225  in providing, to inpatients, skilled nursing care and related
  226  services for patients who require medical or nursing care, or
  227  rehabilitation services for the rehabilitation of injured,
  228  disabled, or sick persons.
  229         (17) “Tertiary health service” means a health service
  230  which, due to its high level of intensity, complexity,
  231  specialized or limited applicability, and cost, should be
  232  limited to, and concentrated in, a limited number of hospitals
  233  to ensure the quality, availability, and cost-effectiveness of
  234  such service. Examples of such service include, but are not
  235  limited to, pediatric cardiac catheterization, pediatric open
  236  heart surgery, organ transplantation, neonatal intensive care
  237  units, comprehensive rehabilitation, and medical or surgical
  238  services which are experimental or developmental in nature to
  239  the extent that the provision of such services is not yet
  240  contemplated within the commonly accepted course of diagnosis or
  241  treatment for the condition addressed by a given service. The
  242  agency shall establish by rule a list of all tertiary health
  243  services.
  244         Section 7. Effective July 1, 2021, subsection (8), and
  245  subsections (9) through (11), as amended by this act, of section
  246  408.032, Florida Statutes, are amended to read:
  247         408.032 Definitions relating to Health Facility and
  248  Services Development Act.—As used in ss. 408.031-408.045, the
  249  term:
  250         (8) “Health care facility” means a hospital, skilled
  251  nursing facility, hospice, or intermediate care facility for the
  252  developmentally disabled. A facility relying solely on spiritual
  253  means through prayer for healing is not included as a health
  254  care facility.
  255         (9) “Health services” means inpatient diagnostic, curative,
  256  or comprehensive medical rehabilitative services and includes
  257  mental health services. Obstetric services are not health
  258  services for purposes of ss. 408.031-408.045.
  259         (9)(10) “Hospice” or “hospice program” means a hospice as
  260  defined in part IV of chapter 400.
  261         (11) “Hospital” means a health care facility licensed under
  262  chapter 395.
  263         (10)(12) “Intermediate care facility for the
  264  developmentally disabled” means a residential facility licensed
  265  under part VIII of chapter 400.
  266         (11)(13) “Nursing home geographically underserved area”
  267  means:
  268         (a) A county in which there is no existing or approved
  269  nursing home;
  270         (b) An area with a radius of at least 20 miles in which
  271  there is no existing or approved nursing home; or
  272         (c) An area with a radius of at least 20 miles in which all
  273  existing nursing homes have maintained at least a 95 percent
  274  occupancy rate for the most recent 6 months or a 90 percent
  275  occupancy rate for the most recent 12 months.
  276         (12)(14) “Skilled nursing facility” means an institution,
  277  or a distinct part of an institution, which is primarily engaged
  278  in providing, to inpatients, skilled nursing care and related
  279  services for patients who require medical or nursing care, or
  280  rehabilitation services for the rehabilitation of injured,
  281  disabled, or sick persons.
  282         Section 8. Effective July 1, 2021, paragraph (b) of
  283  subsection (1) of section 408.033, Florida Statutes, is amended
  284  to read:
  285         408.033 Local and state health planning.—
  286         (1) LOCAL HEALTH COUNCILS.—
  287         (b) Each local health council may:
  288         1. Develop a district area health plan that permits each
  289  local health council to develop strategies and set priorities
  290  for implementation based on its unique local health needs.
  291         2. Advise the agency on health care issues and resource
  292  allocations.
  293         3. Promote public awareness of community health needs,
  294  emphasizing health promotion and cost-effective health service
  295  selection.
  296         4. Collect data and conduct analyses and studies related to
  297  health care needs of the district, including the needs of
  298  medically indigent persons, and assist the agency and other
  299  state agencies in carrying out data collection activities that
  300  relate to the functions in this subsection.
  301         5. Monitor the onsite construction progress, if any, of
  302  certificate-of-need approved projects and report council
  303  findings to the agency on forms provided by the agency.
  304         6. Advise and assist any regional planning councils within
  305  each district that have elected to address health issues in
  306  their strategic regional policy plans with the development of
  307  the health element of the plans to address the health goals and
  308  policies in the State Comprehensive Plan.
  309         7. Advise and assist local governments within each district
  310  on the development of an optional health plan element of the
  311  comprehensive plan provided in chapter 163, to assure
  312  compatibility with the health goals and policies in the State
  313  Comprehensive Plan and district health plan. To facilitate the
  314  implementation of this section, the local health council shall
  315  annually provide the local governments in its service area, upon
  316  request, with:
  317         a. A copy and appropriate updates of the district health
  318  plan;
  319         b. A report of hospital and nursing home utilization
  320  statistics for facilities within the local government
  321  jurisdiction; and
  322         c. Applicable agency rules and calculated need
  323  methodologies for health facilities and services regulated under
  324  s. 408.034 for the district served by the local health council.
  325         8. Monitor and evaluate the adequacy, appropriateness, and
  326  effectiveness, within the district, of local, state, federal,
  327  and private funds distributed to meet the needs of the medically
  328  indigent and other underserved population groups.
  329         9. In conjunction with the Department of Health, plan for
  330  services at the local level for persons infected with the human
  331  immunodeficiency virus.
  332         10. Provide technical assistance to encourage and support
  333  activities by providers, purchasers, consumers, and local,
  334  regional, and state agencies in meeting the health care goals,
  335  objectives, and policies adopted by the local health council.
  336         11. Provide the agency with data required by rule for the
  337  review of certificate-of-need applications and the projection of
  338  need for health services and facilities in the district.
  339         Section 9. Subsection (2) of section 408.034, Florida
  340  Statutes, is amended to read:
  341         408.034 Duties and responsibilities of agency; rules.—
  342         (2) In the exercise of its authority to issue licenses to
  343  health care facilities and health service providers, as provided
  344  under chapters 393 and 395 and parts II, IV, and VIII of chapter
  345  400, the agency may not issue a license to any health care
  346  facility or health service provider that fails to receive a
  347  certificate of need or an exemption for the licensed facility,
  348  except that the agency may issue a license to a general hospital
  349  that has not been issued a certificate of need or service.
  350         Section 10. Effective July 1, 2021, subsection (2), as
  351  amended by this act, and subsection (3) of section 408.034,
  352  Florida Statutes, are amended to read:
  353         408.034 Duties and responsibilities of agency; rules.—
  354         (2) In the exercise of its authority to issue licenses to
  355  health care facilities, as provided under chapter chapters 393
  356  and 395 and parts II, IV, and VIII of chapter 400, the agency
  357  may not issue a license to any health care facility that fails
  358  to receive a certificate of need or an exemption for the
  359  licensed facility, except that the agency may issue a license to
  360  a general hospital that has not been issued a certificate of
  361  need.
  362         (3) The agency shall establish, by rule, uniform need
  363  methodologies for health services and health facilities. In
  364  developing uniform need methodologies, the agency shall, at a
  365  minimum, consider the demographic characteristics of the
  366  population, the health status of the population, service use
  367  patterns, standards and trends, geographic accessibility, and
  368  market economics.
  369         Section 11. Section 408.035, Florida Statutes, is amended
  370  to read:
  371         408.035 Review criteria.—
  372         (1) The agency shall determine the reviewability of
  373  applications and shall review applications for certificate-of
  374  need determinations for health care facilities and health
  375  services in context with the following criteria, except for
  376  general hospitals as defined in s. 395.002:
  377         (1)(a) The need for the health care facilities and health
  378  services being proposed.
  379         (2)(b) The availability, quality of care, accessibility,
  380  and extent of utilization of existing health care facilities and
  381  health services in the service district of the applicant.
  382         (3)(c) The ability of the applicant to provide quality of
  383  care and the applicant’s record of providing quality of care.
  384         (4)(d) The availability of resources, including health
  385  personnel, management personnel, and funds for capital and
  386  operating expenditures, for project accomplishment and
  387  operation.
  388         (5)(e) The extent to which the proposed services will
  389  enhance access to health care for residents of the service
  390  district.
  391         (6)(f) The immediate and long-term financial feasibility of
  392  the proposal.
  393         (7)(g) The extent to which the proposal will foster
  394  competition that promotes quality and cost-effectiveness.
  395         (8)(h) The costs and methods of the proposed construction,
  396  including the costs and methods of energy provision and the
  397  availability of alternative, less costly, or more effective
  398  methods of construction.
  399         (9)(i) The applicant’s past and proposed provision of
  400  health care services to Medicaid patients and the medically
  401  indigent.
  402         (10)(j) The applicant’s designation as a Gold Seal Program
  403  nursing facility pursuant to s. 400.235, when the applicant is
  404  requesting additional nursing home beds at that facility.
  405         (2) For a general hospital, the agency shall consider only
  406  the criteria specified in paragraph (1)(a), paragraph (1)(b),
  407  except for quality of care in paragraph (1)(b), and paragraphs
  408  (1)(e), (g), and (i).
  409         Section 12. Effective July 1, 2021, subsection (2) of
  410  section 408.035, Florida Statutes, as amended by this act, is
  411  amended to read:
  412         408.035 Review criteria.—The agency shall determine the
  413  reviewability of applications and shall review applications for
  414  certificate-of-need determinations for health care facilities in
  415  context with the following criteria:
  416         (2) The availability, quality of care, accessibility, and
  417  extent of utilization of existing health care facilities and
  418  health services in the service district of the applicant.
  419         Section 13. Subsection (1) and paragraphs (i) through (q)
  420  of subsection (3) of section 408.036, Florida Statutes, are
  421  amended to read:
  422         408.036 Projects subject to review; exemptions.—
  423         (1) APPLICABILITY.—Unless exempt under subsection (3), all
  424  health-care-related projects, as described in this subsection
  425  paragraphs (a)-(f), are subject to review and must file an
  426  application for a certificate of need with the agency. The
  427  agency is exclusively responsible for determining whether a
  428  health-care-related project is subject to review under ss.
  429  408.031-408.045.
  430         (a) The addition of beds in community nursing homes or
  431  intermediate care facilities for the developmentally disabled by
  432  new construction or alteration.
  433         (b) The new construction or establishment of additional
  434  health care facilities, except for the construction of or
  435  establishment of a general hospital or including a replacement
  436  health care facility when the proposed project site is not
  437  located on the same site as or within 1 mile of the existing
  438  health care facility, if the number of beds in each licensed bed
  439  category will not increase.
  440         (c) The conversion from one type of health care facility to
  441  another, including the conversion from a general hospital or, a
  442  specialty hospital, except that the conversion of a specialty
  443  hospital to a general hospital is not subject to review or a
  444  long-term care hospital.
  445         (d) The establishment of a hospice or hospice inpatient
  446  facility, except as provided in s. 408.043.
  447         (e)An increase in the number of beds for comprehensive
  448  rehabilitation.
  449         (f)The establishment of tertiary health services,
  450  including inpatient comprehensive rehabilitation services.
  451         (3) EXEMPTIONS.—Upon request, the following projects are
  452  subject to exemption from the provisions of subsection (1):
  453         (i)For the addition of hospital beds licensed under
  454  chapter 395 for comprehensive rehabilitation in a number that
  455  may not exceed 10 total beds or 10 percent of the licensed
  456  capacity, whichever is greater.
  457         1.In addition to any other documentation otherwise
  458  required by the agency, a request for exemption submitted under
  459  this paragraph must:
  460         a.Certify that the prior 12-month average occupancy rate
  461  for the licensed beds being expanded meets or exceeds 80
  462  percent.
  463         b.Certify that the beds have been licensed and operational
  464  for at least 12 months.
  465         2.The timeframes and monitoring process specified in s.
  466  408.040(2)(a)-(c) apply to any exemption issued under this
  467  paragraph.
  468         3.The agency shall count beds authorized under this
  469  paragraph as approved beds in the published inventory of
  470  hospital beds until the beds are licensed.
  471         (i)(j) For the addition of nursing home beds licensed under
  472  chapter 400 in a number not exceeding 10 total beds or 10
  473  percent of the number of beds licensed in the facility being
  474  expanded, whichever is greater; or, for the addition of nursing
  475  home beds licensed under chapter 400 at a facility that has been
  476  designated as a Gold Seal nursing home under s. 400.235 in a
  477  number not exceeding 20 total beds or 10 percent of the number
  478  of licensed beds in the facility being expanded, whichever is
  479  greater.
  480         1. In addition to any other documentation required by the
  481  agency, a request for exemption submitted under this paragraph
  482  must certify that:
  483         a. The facility has not had any class I or class II
  484  deficiencies within the 30 months preceding the request.
  485         b. The prior 12-month average occupancy rate for the
  486  nursing home beds at the facility meets or exceeds 94 percent.
  487         c. Any beds authorized for the facility under this
  488  paragraph before the date of the current request for an
  489  exemption have been licensed and operational for at least 12
  490  months.
  491         2. The timeframes and monitoring process specified in s.
  492  408.040(2)(a)-(c) apply to any exemption issued under this
  493  paragraph.
  494         3. The agency shall count beds authorized under this
  495  paragraph as approved beds in the published inventory of nursing
  496  home beds until the beds are licensed.
  497         (k)For the establishment of:
  498         1.A Level II neonatal intensive care unit with at least 10
  499  beds, upon documentation to the agency that the applicant
  500  hospital had a minimum of 1,500 births during the previous 12
  501  months;
  502         2.A Level III neonatal intensive care unit with at least
  503  15 beds, upon documentation to the agency that the applicant
  504  hospital has a Level II neonatal intensive care unit of at least
  505  10 beds and had a minimum of 3,500 births during the previous 12
  506  months; or
  507         3.A Level III neonatal intensive care unit with at least 5
  508  beds, upon documentation to the agency that the applicant
  509  hospital is a verified trauma center pursuant to s.
  510  395.4001(15), and has a Level II neonatal intensive care unit,
  511  
  512  if the applicant demonstrates that it meets the requirements for
  513  quality of care, nurse staffing, physician staffing, physical
  514  plant, equipment, emergency transportation, and data reporting
  515  found in agency certificate-of-need rules for Level II and Level
  516  III neonatal intensive care units and if the applicant commits
  517  to the provision of services to Medicaid and charity patients at
  518  a level equal to or greater than the district average. Such a
  519  commitment is subject to s. 408.040.
  520         (l)For the addition of mental health services or beds if
  521  the applicant commits to providing services to Medicaid or
  522  charity care patients at a level equal to or greater than the
  523  district average. Such a commitment is subject to s. 408.040.
  524         (j)(m) For replacement of a licensed nursing home on the
  525  same site, or within 5 miles of the same site if within the same
  526  subdistrict, if the number of licensed beds does not increase
  527  except as permitted under paragraph (e).
  528         (k)(n) For consolidation or combination of licensed nursing
  529  homes or transfer of beds between licensed nursing homes within
  530  the same planning district, by nursing homes with any shared
  531  controlled interest within that planning district, if there is
  532  no increase in the planning district total number of nursing
  533  home beds and the site of the relocation is not more than 30
  534  miles from the original location.
  535         (l)(o) For beds in state mental health treatment facilities
  536  defined in s. 394.455 and state mental health forensic
  537  facilities operated under chapter 916.
  538         (m)(p) For beds in state developmental disabilities centers
  539  as defined in s. 393.063.
  540         (n)(q) For the establishment of a health care facility or
  541  project that meets all of the following criteria:
  542         1. The applicant was previously licensed within the past 21
  543  days as a health care facility or provider that is subject to
  544  subsection (1).
  545         2. The applicant failed to submit a renewal application and
  546  the license expired on or after January 1, 2015.
  547         3. The applicant does not have a license denial or
  548  revocation action pending with the agency at the time of the
  549  request.
  550         4. The applicant’s request is for the same service type,
  551  district, service area, and site for which the applicant was
  552  previously licensed.
  553         5. The applicant’s request, if applicable, includes the
  554  same number and type of beds as were previously licensed.
  555         6. The applicant agrees to the same conditions that were
  556  previously imposed on the certificate of need or on an exemption
  557  related to the applicant’s previously licensed health care
  558  facility or project.
  559         7. The applicant applies for initial licensure as required
  560  under s. 408.806 within 21 days after the agency approves the
  561  exemption request. If the applicant fails to apply in a timely
  562  manner, the exemption expires on the 22nd day following the
  563  agency’s approval of the exemption.
  564  
  565  Notwithstanding subparagraph 1., an applicant whose license
  566  expired between January 1, 2015, and the effective date of this
  567  act may apply for an exemption within 30 days of this act
  568  becoming law.
  569         Section 14. Effective July 1, 2021, paragraphs (b), (c),
  570  (l), (m), and (n) of subsection (1), as amended by this act, and
  571  subsections (2) and (5) of section 408.036, Florida Statutes,
  572  are amended to read:
  573         408.036 Projects subject to review; exemptions.—
  574         (1) APPLICABILITY.—Unless exempt under subsection (3), all
  575  health-care-related projects, as described in this subsection,
  576  are subject to review and must file an application for a
  577  certificate of need with the agency. The agency is exclusively
  578  responsible for determining whether a health-care-related
  579  project is subject to review under ss. 408.031-408.045.
  580         (b) The new construction or establishment of additional
  581  health care facilities, except for the construction of or
  582  establishment of a general hospital or a replacement health care
  583  facility when the proposed project site is located on the same
  584  site as or within 1 mile of the existing health care facility if
  585  the number of beds in each licensed bed category will not
  586  increase.
  587         (c) The conversion from one type of health care facility to
  588  another, including the conversion from a general hospital or a
  589  specialty hospital, except that the conversion of a specialty
  590  hospital to a general hospital is not subject to review.
  591         (l)For beds in state mental health treatment facilities
  592  defined in s. 394.455 and state mental health forensic
  593  facilities operated under chapter 916.
  594         (l)(m) For beds in state developmental disabilities centers
  595  as defined in s. 393.063.
  596         (m)(n) For the establishment of a health care facility or
  597  project that meets all of the following criteria:
  598         1. The applicant was previously licensed within the past 21
  599  days as a health care facility or provider that is subject to
  600  subsection (1).
  601         2. The applicant failed to submit a renewal application and
  602  the license expired on or after January 1, 2015.
  603         3. The applicant does not have a license denial or
  604  revocation action pending with the agency at the time of the
  605  request.
  606         4. The applicant’s request is for the same service type,
  607  district, service area, and site for which the applicant was
  608  previously licensed.
  609         5. The applicant’s request, if applicable, includes the
  610  same number and type of beds as were previously licensed.
  611         6. The applicant agrees to the same conditions that were
  612  previously imposed on the certificate of need or on an exemption
  613  related to the applicant’s previously licensed health care
  614  facility or project.
  615         7. The applicant applies for initial licensure as required
  616  under s. 408.806 within 21 days after the agency approves the
  617  exemption request. If the applicant fails to apply in a timely
  618  manner, the exemption expires on the 22nd day following the
  619  agency’s approval of the exemption.
  620         (2) PROJECTS SUBJECT TO EXPEDITED REVIEW.—Unless exempt
  621  pursuant to subsection (3), the following projects are subject
  622  to expedited review:
  623         (a) Transfer of a certificate of need, except that when an
  624  existing hospital is acquired by a purchaser, all certificates
  625  of need issued to the hospital which are not yet operational
  626  shall be acquired by the purchaser without need for a transfer.
  627         (5) NOTIFICATION.—Health care facilities and providers must
  628  provide to the agency notification of:
  629         (a) replacement of a health care facility when the proposed
  630  project site is located in the same district and on the existing
  631  site or within a 1-mile radius of the replaced health care
  632  facility, if the number and type of beds do not increase.
  633         (b)The termination of a health care service, upon 30 days’
  634  written notice to the agency.
  635         (c)The addition or delicensure of beds. Notification under
  636  this subsection may be made by electronic, facsimile, or written
  637  means at any time before the described action has been taken.
  638         Section 15. Section 408.0361, Florida Statutes, is
  639  repealed.
  640         Section 16. Section 408.037, Florida Statutes, is amended
  641  to read:
  642         408.037 Application content.—
  643         (1) Except as provided in subsection (2) for a general
  644  hospital, An application for a certificate of need must contain:
  645         (a) A detailed description of the proposed project and
  646  statement of its purpose and need in relation to the district
  647  health plan.
  648         (b) A statement of the financial resources needed by and
  649  available to the applicant to accomplish the proposed project.
  650  This statement must include:
  651         1. A complete listing of all capital projects, including
  652  new health facility development projects and health facility
  653  acquisitions applied for, pending, approved, or underway in any
  654  state at the time of application, regardless of whether or not
  655  that state has a certificate-of-need program or a capital
  656  expenditure review program pursuant to s. 1122 of the Social
  657  Security Act. The agency may, by rule, require less-detailed
  658  information from major health care providers. This listing must
  659  include the applicant’s actual or proposed financial commitment
  660  to those projects and an assessment of their impact on the
  661  applicant’s ability to provide the proposed project.
  662         2. A detailed listing of the needed capital expenditures,
  663  including sources of funds.
  664         3. A detailed financial projection, including a statement
  665  of the projected revenue and expenses for the first 2 years of
  666  operation after completion of the proposed project. This
  667  statement must include a detailed evaluation of the impact of
  668  the proposed project on the cost of other services provided by
  669  the applicant.
  670         (c) An audited financial statement of the applicant or the
  671  applicant’s parent corporation if audited financial statements
  672  of the applicant do not exist. In an application submitted by an
  673  existing health care facility, health maintenance organization,
  674  or hospice, financial condition documentation must include, but
  675  need not be limited to, a balance sheet and a profit-and-loss
  676  statement of the 2 previous fiscal years’ operation.
  677         (2) An application for a certificate of need for a general
  678  hospital must contain a detailed description of the proposed
  679  general hospital project and a statement of its purpose and the
  680  needs it will meet. The proposed project’s location, as well as
  681  its primary and secondary service areas, must be identified by
  682  zip code. Primary service area is defined as the zip codes from
  683  which the applicant projects that it will draw 75 percent of its
  684  discharges. Secondary service area is defined as the zip codes
  685  from which the applicant projects that it will draw its
  686  remaining discharges. If, subsequent to issuance of a final
  687  order approving the certificate of need, the proposed location
  688  of the general hospital changes or the primary service area
  689  materially changes, the agency shall revoke the certificate of
  690  need. However, if the agency determines that such changes are
  691  deemed to enhance access to hospital services in the service
  692  district, the agency may permit such changes to occur. A party
  693  participating in the administrative hearing regarding the
  694  issuance of the certificate of need for a general hospital has
  695  standing to participate in any subsequent proceeding regarding
  696  the revocation of the certificate of need for a hospital for
  697  which the location has changed or for which the primary service
  698  area has materially changed. In addition, the application for
  699  the certificate of need for a general hospital must include a
  700  statement of intent that, if approved by final order of the
  701  agency, the applicant shall within 120 days after issuance of
  702  the final order or, if there is an appeal of the final order,
  703  within 120 days after the issuance of the court’s mandate on
  704  appeal, furnish satisfactory proof of the applicant’s financial
  705  ability to operate. The agency shall establish documentation
  706  requirements, to be completed by each applicant, which show
  707  anticipated provider revenues and expenditures, the basis for
  708  financing the anticipated cash-flow requirements of the
  709  provider, and an applicant’s access to contingency financing. A
  710  party participating in the administrative hearing regarding the
  711  issuance of the certificate of need for a general hospital may
  712  provide written comments concerning the adequacy of the
  713  financial information provided, but such party does not have
  714  standing to participate in an administrative proceeding
  715  regarding proof of the applicant’s financial ability to operate.
  716  The agency may require a licensee to provide proof of financial
  717  ability to operate at any time if there is evidence of financial
  718  instability, including, but not limited to, unpaid expenses
  719  necessary for the basic operations of the provider.
  720         (2)(3) The applicant must certify that it will license and
  721  operate the health care facility. For an existing health care
  722  facility, the applicant must be the licenseholder of the
  723  facility.
  724         Section 17. Paragraphs (c) and (d) of subsection (3),
  725  paragraphs (b) and (c) of subsection (5), and paragraph (d) of
  726  subsection (6) of section 408.039, Florida Statutes, are amended
  727  to read:
  728         408.039 Review process.—The review process for certificates
  729  of need shall be as follows:
  730         (3) APPLICATION PROCESSING.—
  731         (c) Except for competing applicants, in order to be
  732  eligible to challenge the agency decision on a general hospital
  733  application under review pursuant to paragraph (5)(c), existing
  734  hospitals must submit a detailed written statement of opposition
  735  to the agency and to the applicant. The detailed written
  736  statement must be received by the agency and the applicant
  737  within 21 days after the general hospital application is deemed
  738  complete and made available to the public.
  739         (d) In those cases where a written statement of opposition
  740  has been timely filed regarding a certificate of need
  741  application for a general hospital, the applicant for the
  742  general hospital may submit a written response to the agency.
  743  Such response must be received by the agency within 10 days of
  744  the written statement due date.
  745         (5) ADMINISTRATIVE HEARINGS.—
  746         (b) Hearings shall be held in Tallahassee unless the
  747  administrative law judge determines that changing the location
  748  will facilitate the proceedings. The agency shall assign
  749  proceedings requiring hearings to the Division of Administrative
  750  Hearings of the Department of Management Services within 10 days
  751  after the time has expired for requesting a hearing. Except upon
  752  unanimous consent of the parties or upon the granting by the
  753  administrative law judge of a motion of continuance, hearings
  754  shall commence within 60 days after the administrative law judge
  755  has been assigned. For an application for a general hospital,
  756  administrative hearings shall commence within 6 months after the
  757  administrative law judge has been assigned, and a continuance
  758  may not be granted absent a finding of extraordinary
  759  circumstances by the administrative law judge. All parties,
  760  except the agency, shall bear their own expense of preparing a
  761  transcript. In any application for a certificate of need which
  762  is referred to the Division of Administrative Hearings for
  763  hearing, the administrative law judge shall complete and submit
  764  to the parties a recommended order as provided in ss. 120.569
  765  and 120.57. The recommended order shall be issued within 30 days
  766  after the receipt of the proposed recommended orders or the
  767  deadline for submission of such proposed recommended orders,
  768  whichever is earlier. The division shall adopt procedures for
  769  administrative hearings which shall maximize the use of
  770  stipulated facts and shall provide for the admission of prepared
  771  testimony.
  772         (c) In administrative proceedings challenging the issuance
  773  or denial of a certificate of need, only applicants considered
  774  by the agency in the same batching cycle are entitled to a
  775  comparative hearing on their applications. Existing health care
  776  facilities may initiate or intervene in an administrative
  777  hearing upon a showing that an established program will be
  778  substantially affected by the issuance of any certificate of
  779  need, whether reviewed under s. 408.036(1) or (2), to a
  780  competing proposed facility or program within the same district.
  781  With respect to an application for a general hospital, competing
  782  applicants and only those existing hospitals that submitted a
  783  detailed written statement of opposition to an application as
  784  provided in this paragraph may initiate or intervene in an
  785  administrative hearing. Such challenges to a general hospital
  786  application shall be limited in scope to the issues raised in
  787  the detailed written statement of opposition that was provided
  788  to the agency. The administrative law judge may, upon a motion
  789  showing good cause, expand the scope of the issues to be heard
  790  at the hearing. Such motion shall include substantial and
  791  detailed facts and reasons for failure to include such issues in
  792  the original written statement of opposition.
  793         (6) JUDICIAL REVIEW.—
  794         (d) The party appealing a final order that grants a general
  795  hospital certificate of need shall pay the appellee’s attorney’s
  796  fees and costs, in an amount up to $1 million, from the
  797  beginning of the original administrative action if the appealing
  798  party loses the appeal, subject to the following limitations and
  799  requirements:
  800         1. The party appealing a final order must post a bond in
  801  the amount of $1 million in order to maintain the appeal.
  802         2. Except as provided under s. 120.595(5), in no event
  803  shall the agency be held liable for any other party’s attorney’s
  804  fees or costs.
  805         Section 18. Subsection (1) of section 408.043, Florida
  806  Statutes, is amended to read:
  807         408.043 Special provisions.—
  808         (1) OSTEOPATHIC ACUTE CARE HOSPITALS.—When an application
  809  is made for a certificate of need to construct or to expand an
  810  osteopathic acute care hospital, the need for such hospital
  811  shall be determined on the basis of the need for and
  812  availability of osteopathic services and osteopathic acute care
  813  hospitals in the district. When a prior certificate of need to
  814  establish an osteopathic acute care hospital has been issued in
  815  a district, and the facility is no longer used for that purpose,
  816  the agency may continue to count such facility and beds as an
  817  existing osteopathic facility in any subsequent application for
  818  construction of an osteopathic acute care hospital.
  819         Section 19. Section 408.0455, Florida Statutes, is amended
  820  to read:
  821         408.0455 Rules; pending proceedings.—The rules of the
  822  agency in effect on June 30, 2004, shall remain in effect and
  823  shall be enforceable by the agency with respect to ss. 408.031
  824  408.045 until such rules are repealed or amended by the agency.
  825  Rules 59C-1.039 through 59C-1.044, F.A.C., remain in effect for
  826  the sole purpose of maintaining licensure requirements for the
  827  applicable services until the agency has adopted rules for the
  828  corresponding services pursuant to s. 395.1055(1)(i), Florida
  829  Statutes 2018.
  830         Section 20. Subsection (3) of section 408.808, Florida
  831  Statutes, is amended to read:
  832         408.808 License categories.—
  833         (3) INACTIVE LICENSE.—An inactive license may be issued to
  834  a hospital or a health care provider subject to the certificate
  835  of-need provisions in part I of this chapter when the provider
  836  is currently licensed, does not have a provisional license, and
  837  will be temporarily unable to provide services but is reasonably
  838  expected to resume services within 12 months. Such designation
  839  may be made for a period not to exceed 12 months but may be
  840  renewed by the agency for up to 12 additional months upon
  841  demonstration by the licensee of the provider’s progress toward
  842  reopening. However, if after 20 months in an inactive license
  843  status, a statutory rural hospital, as defined in s. 395.602,
  844  has demonstrated progress toward reopening, but may not be able
  845  to reopen prior to the inactive license expiration date, the
  846  inactive designation may be renewed again by the agency for up
  847  to 12 additional months. For purposes of such a second renewal,
  848  if construction or renovation is required, the licensee must
  849  have had plans approved by the agency and construction must have
  850  already commenced pursuant to s. 408.032(4); however, if
  851  construction or renovation is not required, the licensee must
  852  provide proof of having made an enforceable capital expenditure
  853  greater than 25 percent of the total costs associated with the
  854  hiring of staff and the purchase of equipment and supplies
  855  needed to operate the facility upon opening. A request by a
  856  licensee for an inactive license or to extend the previously
  857  approved inactive period must be submitted to the agency and
  858  must include a written justification for the inactive license
  859  with the beginning and ending dates of inactivity specified, a
  860  plan for the transfer of any clients to other providers, and the
  861  appropriate licensure fees. The agency may not accept a request
  862  that is submitted after initiating closure, after any suspension
  863  of service, or after notifying clients of closure or suspension
  864  of service, unless the action is a result of a disaster at the
  865  licensed premises. For the purposes of this section, the term
  866  “disaster” means a sudden emergency occurrence beyond the
  867  control of the licensee, whether natural, technological, or
  868  manmade, which renders the provider inoperable at the premises.
  869  Upon agency approval, the provider shall notify clients of any
  870  necessary discharge or transfer as required by authorizing
  871  statutes or applicable rules. The beginning of the inactive
  872  license period is the date the provider ceases operations. The
  873  end of the inactive license period shall become the license
  874  expiration date. All licensure fees must be current, must be
  875  paid in full, and may be prorated. Reactivation of an inactive
  876  license requires the approval of a renewal application,
  877  including payment of licensure fees and agency inspections
  878  indicating compliance with all requirements of this part,
  879  authorizing statutes, and applicable rules.
  880         Section 21. The Office of Program Policy Analysis and
  881  Government Accountability shall review federal requirements and
  882  other states’ licensure statutes and rules governing the
  883  provision of tertiary health services as defined in s. 408.032,
  884  Florida Statutes 2018, and shall make recommendations to the
  885  President of the Senate and the Speaker of the House of
  886  Representatives on best practices, including recommendations on
  887  minimum volume requirements, as applicable, regarding the
  888  establishment of licensure standards for such programs by
  889  November 1, 2019.
  890         Section 22. Except as otherwise expressly provided in this
  891  act, this act shall take effect July 1, 2019.
  892  
  893  ================= T I T L E  A M E N D M E N T ================
  894  And the title is amended as follows:
  895         Delete everything before the enacting clause
  896  and insert:
  897                        A bill to be entitled                      
  898         An act relating to hospital licensure; amending s.
  899         395.0191, F.S.; deleting provisions relating to
  900         certificate of need applications; amending s.
  901         395.1055, F.S.; revising the Agency for Health Care
  902         Administration’s rulemaking authority with respect to
  903         minimum standards for hospitals; requiring hospitals
  904         that provide certain services to meet specified
  905         licensure requirements; conforming provisions to
  906         changes made by the act; amending s. 395.1065, F.S.;
  907         conforming a cross-reference; repealing s. 395.6025,
  908         F.S., relating to rural hospital replacement
  909         facilities; amending s. 408.032, F.S.; revising and
  910         deleting definitions; amending s. 408.033, F.S.;
  911         conforming provisions to changes made by the act;
  912         amending s. 408.034, F.S.; authorizing the agency to
  913         issue a license to a general hospital that has not
  914         been issued a certificate of need under certain
  915         circumstances; revising duties and responsibilities of
  916         the agency relating to issuance of licenses to health
  917         care facilities and health service providers;
  918         conforming provisions to changes made by the act;
  919         amending s. 408.035, F.S.; deleting provisions related
  920         to the agency’s consideration and review of
  921         applications for certificates of need for general
  922         hospitals and health services; amending s. 408.036,
  923         F.S.; providing an exception to certificate of need
  924         review requirements for the construction or
  925         establishment of a general hospital and the conversion
  926         of a specialty hospital to a general hospital;
  927         revising health-care-related projects that are subject
  928         to agency review for a certificate of need and
  929         exemptions therefrom; deleting provisions requiring
  930         health care facilities and providers to provide
  931         certain notice to the agency upon termination of a
  932         health care service or the addition or delicensure of
  933         beds; conforming a provision to changes made by the
  934         act; repealing s. 408.0361, F.S., relating to
  935         cardiovascular services and burn unit licensure;
  936         amending ss. 408.037 and 408.039, F.S.; deleting
  937         provisions relating to certificate of need
  938         applications for general hospitals; amending s.
  939         408.043, F.S.; deleting provisions relating to
  940         certificates of need for osteopathic acute care
  941         hospitals; amending s. 408.0455, F.S.; establishing
  942         that specified rules remain in effect for a specified
  943         purpose and until the agency has adopted certain
  944         rules; amending s. 408.808, F.S.; authorizing the
  945         agency to issue an inactive license to a certain
  946         hospital under certain circumstances; requiring the
  947         Office of Program Policy Analysis and Government
  948         Accountability to review specified requirements,
  949         statutes, and rules, and make recommendations to the
  950         Legislature by a specified date; providing effective
  951         dates.